Drug delivery device with electronics

ABSTRACT

A device for delivering medication to a user may include a main body, an electronics module, and a slider. The main body may include a mouthpiece, a medication reservoir, and a mouthpiece cover, where the mouthpiece cover may be hinged to the main body. The electronics module may include a communication circuit, a pressure sensor, and a switch. The slider may be configured to engage the switch when the mouthpiece cover moves from a closed position to an open position. The switch may be configured to switch the electronics module from an off state or a sleep state to an active state. The electronics module may be configured to never return to the off state after the mouthpiece cover is moved to expose the mouthpiece for the first time by the user.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of Provisional U.S. PatentApplication No. 62/424,306, filed Nov. 18, 2016, the disclosure of whichis incorporated herein by reference in its entirety.

BACKGROUND

Drug delivery devices facilitate the delivery of medication into apatient's body via various routes of administration. Typical routes ofadministration include oral, topical, sublingual inhalation, injectionand the like. The devices may be used to deliver medications for thetreatment various diseases, ailments and medical conditions. Inhalationdevices, for example, may be used to treat asthma, chronic obstructivepulmonary disease (COPD) and cystic fibrosis (CF). While drug deliverydevices are designed to deliver an appropriate dose of medication to apatient as part of a therapeutic treatment, the effectiveness of aparticular treatment may be influenced by non-physiological factors,such as the patient's adherence and compliance.

In the context of a drug therapy, adherence may refer to the degree towhich a patient is following a prescribed dosing regimen. For example,if the patient's prescription calls for two doses each day, and thepatient is taking two doses per day, the patient may be considered 100%adherent. If the patient is only taking one dose per day, he or she maybe deemed only 50% adherent. In the latter case, the patient may not bereceiving the treatment prescribed by his or her doctor, which maynegatively affect the efficacy of the therapeutic treatment.

Compliance may refer to a patient's technique when using a particulardrug delivery device. If the patient is using the device in a mannerthat is recommended by a doctor or by a manufacturer, the device islikely to deliver the desired dose of medication and the patient may bedeemed compliant. However, if the device is not being used properlyduring drug administration, the device's ability to deliver a properdose of medication may be compromised. As such, the patient may bedeemed non-compliant. In the case of an inhalation device, for example,the patient may need to achieve a minimum inspiratory effort to ensure afull dose of medication is delivered from the device into the patient'slungs. For some patients, such as children and the elderly, meeting therequirements for full compliance may be difficult due to physicallimitations, such as limited lung function. Accordingly, like adherence,failing to achieve full compliance may reduce the effectiveness of aprescribed treatment.

A patient's ability to achieve full compliance may be furthercomplicated by certain physical properties of the medication. Forexample, some respiratory medications may consist of fine particlesand/or may lack any odor or taste. Thus, a patient using an inhalationdevice may not be able to correct a non-compliant use because he or shemay not be able to immediately detect or sense that medication is beinginhaled and/or know whether the amount of inhaled medication complieswith the prescription.

SUMMARY

A drug delivery device may be adapted to include an electronics modulethat is configured to sense, track, and/or process usage conditions andparameters associated with the device (e.g., to improve adherence andcompliance). The electronics module may be further configured tocommunicate the conditions and parameters to external devices, such as asmartphone, for similar and/or further processing. The inclusion of anelectronics module in a drug delivery device opens the doors to a wealthof digital improvements and features to enhance the use of the device.The electronics module, in this context, may create a platform toleverage helpful smartphone applications and powerful data analytics.However, the introduction of electronics into any drug delivery devicemay introduce certain technical challenges, such as durability,reliability, electro-mechanical integration, power management, and drugdelivery performance. The present disclosure provides solutions forinclusion of certain electrical components with a drug delivery device,such as an inhaler.

Examples of inhalation devices (e.g., breath-actuated inhalers) areprovided herein. The inhalation device may include a main body having amouthpiece and a mouthpiece cover, a slider at least partially disposedwithin the main body, and an electronics module having a switch and apressure sensor. The electronics module may be configured to be in anoff state prior to a user moving the mouthpiece cover to expose themouthpiece for the first time. When the mouthpiece cover is moved toexpose the mouthpiece, the slider may be configured to engage theswitch, which may cause the electronics module to transition from theoff state to an active state and to sense inhalation by the user throughthe mouthpiece. The electronics module may be configured to not returnto the off state after the mouthpiece cover is moved to expose themouthpiece for the first time by the user (e.g., throughout the life ofthe inhalation device and/or battery). The electronics module may beconfigured to start an internal counter when transitioning from the offstate. The electronics module is configured to timestamp inhalationevents, inhalation metrics, error events, pressure measurements,mouthpiece cover opening events, etc. based on the internal counter.

The pressure sensor may be configured to measure a plurality of pressurechanges within the inhaler resulting from the user's inhalation throughthe mouthpiece after the mouthpiece cover is moved from the closedposition to the open position. The pressure sensor may be configured totake measurements for a predetermined period of time or until apredetermined event is detected (e.g., an inhalation, a closing of themouthpiece cover, etc.). The electronics module may also include aprocessor configured to determine one or more inhalation parametersbased on the plurality of measured pressure changes. The inhalationparameters may include, but are not limited to, a peak flow rate, a timeto peak flow rate, an inhaled volume, and an inhalation duration. Theelectronics module may also include a communications circuit configuredto wirelessly transmit the inhalation parameters to an external device.

When in the active state, the electronics module may be configured tomeasure one or more pressure changes within the inhaler resulting fromthe user's inhalation through the mouthpiece, determine inhalationparameters based on the one more measured pressure changes, store theinhalation parameters in a local memory, advertise to an externaldevice, and/or transmit the inhalation parameters to the externaldevice.

The electronics module may be configured to be in a sleep state when notin the off state or the active state. The electronics module may beconfigured to change from the active state to the sleep state upon theelectronics module determining that the pressure measurement receivedfrom a pressure sensor does not fall within the predetermined range fora predetermined amount of time (e.g., a user not inhaling from themouthpiece for the predetermined amount of time), where thepredetermined amount of time is based on the internal counter. Theelectronics module may be configured to store a timeout event andassociated timestamp when the mouthpiece cover is moved to the openposition and the electronics module does not determine that a pressuremeasurement received from the pressure sensor is within thepredetermined range within the predetermined amount of time (e.g., auser not inhaling from the mouthpiece for the predetermined amount oftime), where the timestamp of the timeout event is based on the internalcounter.

Upon determining that the pressure measurement received from a pressuresensor is within the predetermined range, the electronics module may beconfigured to generate an inhalation event and associated timestamp forthe inhalation event, and store the inhalation event and associatedtimestamp in memory of the inhaler, where the timestamp of theinhalation event based on the internal counter. Upon storing theinhalation event and associated timestamp in memory, the electronicsmodule may be configured to cause the communication circuit to transmitadvertisements at a first advertising rate in an attempt to sync up withan external device. If the communication circuit successfully syncs withthe external device, the communication circuit may be configured totransmit the inhalation event and associated timestamp to the externaldevice. If the communication circuit does not successfully sync with theexternal device after a predetermined amount of time, the communicationcircuit may be configured to transmit the advertisements at a secondadvertising rate that is slower than the first advertising rate.

The electronics module may be configured to transition between theactive state and a sleep state at the first rate when the mouthpiececover is in the closed position. The electronics module may beconfigured to cause the communication circuit to transmit advertisementsat a first advertising rate in an attempt to sync up with an externaldevice when the mouthpiece cover is in the open position, and transmitadvertisements at a second advertising rate that is slower than thefirst advertising rate when the mouthpiece cover is in the closedposition.

When in the active state, the electronics module may be configured tosample pressure measurements received from a pressure sensor at apredetermined rate, and configured to power off the sensor systembetween the sampling times of the pressure measurements received fromthe pressure sensor. The electronics module may be configured to performcalculations on the pressure measurements received from the pressuresensor between the sampling times. The electronics module may beconfigured to change from the active state to a sleep state upon themouthpiece cover returning to the closed position.

A system comprising: a mobile application; and a breath-actuated inhalerfor delivering medication to a user, the inhaler comprising amouthpiece, a mouthpiece cover, an electronics module, and a medicationreservoir, the mouthpiece cover hinged to the main body, and theelectronics module comprising a communication circuit, a power supply, asensor system, a battery, and a switch; wherein the electronics moduleis configured to start an internal counter when the mouthpiece cover isfirst moved from a closed position to an open position by a user;wherein the mobile application is configured to query thebreath-actuated inhaler to retrieve event data, the event datacomprising a mouthpiece cover opening event, a timestamp, and inhalationprofile information.

The electronics module is configured to run the internal counter uponwhen the mouthpiece cover is in the closed position and in the openposition after the first time the mouthpiece cover is moved to the openposition by the user. The inhalation profile information comprises oneor more of peak flow of pressure data provided by the sensor system,volume of the pressure data, time-to-peak of the pressure data, orduration of the pressure data. The event data comprises one or more of astatus flag indicating whether an inhalation event was low inhalation,good inhalation, no inhalation, or an exhalation. The event datacomprises information relating to whether the mouthpiece cover is in theopen position or the closed position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of an example inhalation device.

FIG. 2 is a cross-sectional interior perspective view of the exampleinhalation device of FIG. 1.

FIG. 3 is an exploded perspective view of the example inhalation deviceof FIG. 1 with a top cap removed to expose an electronics module.

FIG. 4 is an exploded perspective view of the top cap and theelectronics module of the example inhalation device of FIG. 1.

FIG. 5A is a partial cross-sectional view of the example inhalationdevice of FIG. 1 with a mouthpiece cover of the inhalation device in aclosed position.

FIG. 5B is a partial cross-sectional view of the example inhalationdevice of FIG. 1 with the mouthpiece cover of the inhalation device in apartially open position.

FIG. 5C is a partial cross-sectional view of the example inhalationdevice of FIG. 1 with the mouthpiece cover of the inhalation device in apartially open position.

FIG. 5D is a partial cross-sectional view of the example inhalationdevice of FIG. 1 with the mouthpiece cover of the inhalation device in afully open position.

FIG. 6A and 6B include a flow diagram that illustrates an exampleprocess for transitioning between one or more power states and/oroperational modes associated with the inhalation device.

FIG. 7 is a graph of exemplary airflow rates through the exampleinhalation device of FIG. 1 based on pressure measurements recorded bythe electronics module.

FIG. 8 is a diagram of an example system including an inhalation device.

DETAILED DESCRIPTION

The present disclosure describes devices, systems and methods forsensing, tracking and/or processing usage conditions and parametersassociated with a drug delivery device. The devices, systems and methodsare described in the context of a breath-actuated inhalation device fordelivering medication into a user's lungs. However, the describedsolutions are equally applicable to other drug delivery devices, such asan injector, a metered-dose inhaler, a nebulizer, a transdermal patch,or an implantable.

FIG. 1 is a front perspective view of an example inhalation device 100.FIG. 2 is a cross-sectional interior perspective view of the exampleinhalation device 100. FIG. 3 is an exploded perspective view of theexample inhalation device 100 with a top cap removed to expose anelectronics module. FIG. 4 is an exploded perspective view of the topcap and the electronics module of the example inhalation device 100.

The example, inhalation device 100 may be a breath-actuated inhalationdevice. The inhalation device 100 may include a top cap 102, a mainhousing 104, a mouthpiece 106, a mouthpiece cover 108, an electronicsmodule 120, and an air vent 126. The mouthpiece cover 108 may be hingedto the main housing 104 so that it may open and close to expose themouthpiece 106. Although illustrated as a hinged connection, themouthpiece cover 106 may be connected to the inhalation device 100through other types of connections. Moreover, while the electronicsmodule 120 is illustrated as housed within the top cap 102 at the top ofthe main housing 104, the electronics module 120 may be integratedand/or housed within main body 104 of the inhalation device 100.

Inside the main housing 104, the inhalation device 100 may include amedication reservoir 110 (e.g., a hopper), a bellows 112, a bellowsspring 114, a yoke 118, a dosing cup 116, a dosing chamber 117, adeagglomerator 121 and a flow pathway 119. The medication reservoir 110may include medication, such as dry powder mediation, for delivery tothe user. When the mouthpiece cover 108 is moved to expose themouthpiece 106 (e.g., from a closed position to an open position), thebellows 112 may compress to deliver a dose of medication from themedication reservoir 110 to the dosing cup 116. Thereafter, a user mayinhale through the mouthpiece 106 in an effort to receive the dose ofmedication. The airflow generated from the user's inhalation may causethe deagglomerator 121 to aerosolize the dose of medication by breakingdown the agglomerates of the medicament in the dose cup 116. Thedeagglomerator 121 may be configured to aerosolize the medication whenthe airflow through the flow pathway 119 meets or exceeds a particularrate, or is within a specific range. When aerosolized, the dose ofmedication may travel from the dosing cup 116, into the dosing chamber117, through the flow pathway 119, and out of the mouthpiece 106 to theuser. If the airflow through the flow pathway 119 does not meet orexceed a particular rate, or is not within a specific range, some or allof the medication may remain in the dosing cup 116. In the event thatthe medication in the dosing cup 116 has not been aerosolized by thedeagglomerator 121, another dose of medication may not be delivered fromthe medication reservoir 110 when the mouthpiece cover 108 issubsequently opened. Thus, a single dose of medication may remain in thedosing cup until the dose has been aerosolized by the deagglomerator121.

As the user inhales through the mouthpiece 106, air may enter the airvent 126 to provide a flow of air for delivery of the medication to theuser. The flow pathway 119 may extend from the dosing chamber 117 to theend of the mouthpiece 106, and include the dosing chamber 117 and theinternal portions of the mouthpiece 106. The dosing cup 116 may residewithin or adjacent to the dosing chamber 117. Further, the inhalationdevice 100 may include a dose counter 111 that is configured to beinitially set to a number of total doses of medication within themedication reservoir 110 and to decrease by one each time the mouthpiececover 108 is moved from the closed position to the open position.

The top cap 102 may be attached to the main housing 104. For example,the top cap 102 may be attached to the main housing 104 through the useof one or more clips that engage recesses on the main housing 104. Thetop cap 102 may overlap a portion of the main housing 104 whenconnected, for example, such that a substantially pneumatic seal existsbetween the top cap 102 and the main housing 104. The top surface of themain housing 104 may include one or more (e.g., two) orifices 146. Oneof the orifices 146 may be configured to accept a slider 140. Forexample, when the top cap 102 is attached to the main housing 104, theslider 140 may protrude through the top surface of the main housing 104via one of the orifices 146.

The slider 140 may define an arm 142, a stopper 144, and a distal base145. The distal end 145 may be a bottom portion of the slider 140. Thedistal end 145 of the slider 140 may be configured to abut the yoke 118that resides within the main housing 104 (e.g., and the mouthpiece cover108 is in the closed or partially open position). The distal end 145 maybe configured to abut a top surface of the yoke 118 when the yoke 118 isin any radial orientation. For example, the top surface of the yoke 118may include a plurality of apertures (not shown), and the distal end 145of the slider 140 may be configured to abut the top surface of the yoke118, for example, whether or not one of the apertures is in alignmentwith the slider 140.

The top cap 102 may include a slider guide 148 that is configured toreceive a slider spring 146 and the slider 140. The slider spring 146may reside within the slider guide 148. The slider spring 146 may engagean inner surface of the top cap 102, and the slider spring 146 mayengage (e.g., abut) an upper portion (e.g., a proximate end) of theslider 140. When the slider 140 is installed within the slider guide148, the slider spring 146 may be partially compressed between the topof the slider 140 and the inner surface of the top cap 102. For example,the slider spring 146 may be configured such that the distal end 145 ofthe slider 140 remains in contact with the yoke 118 when the mouthpiececover 108 is closed. The distal end 145 of the slider 145 may alsoremain in contact with the yoke 118 while the mouthpiece cover 108 isbeing opened or closed. The stopper 144 of the slider 140 may engage astopper of the slider guide 148, for example, such that the slider 140is retained within the slider guide 148 through the opening and closingof the mouthpiece cover 108, and vice versa. The stopper 144 and theslider guide 148 may be configured to limit the vertical (e.g., axial)travel of the slider 140. This limit may be less than the verticaltravel of the yoke 118. Thus, as the mouthpiece cover 108 is moved to anopen position, the yoke 118 may continue to move in a vertical directiontowards the mouthpiece 106 but the stopper 144 may stop the verticaltravel of the slider 140 such that the distal end 145 of the slider 140may no longer be in contact with the yoke 118.

The electronics module 120 may include a printed circuit board (PCB)assembly 122, a switch 130, a power supply (e.g., a battery 126), and/ora battery holder 124. The PCB assembly 122 may include may includesurface mounted components, such as a sensor system 128, a wirelesscommunication circuit 129, the switch 130, and or one or more indicators(not shown), such as one or more light emitting diodes (LEDs). Theelectronics module 120 may include a controller (e.g., a processor)and/or memory. The controller and/or memory may be physically distinctcomponents of the PCB 122. Alternatively, the controller and memory maybe part of another chipset mounted on the PCB 122. For example, thewireless communication circuit 129 may include the controller and/ormemory for the electronics module 120. The controller of the electronicsmodule 120 may include a microcontroller, a programmable logic device(PLD), a microprocessor, an application specific integrated circuit(ASIC), a field-programmable gate array (FPGA), or any suitableprocessing device or control circuit.

The controller may access information from, and store data in thememory. The memory may include any type of suitable memory, such asnon-removable memory and/or removable memory. The non-removable memorymay include random-access memory (RAM), read-only memory (ROM), a harddisk, or any other type of memory storage device. The removable memorymay include a subscriber identity module (SIM) card, a memory stick, asecure digital (SD) memory card, and the like. The memory may beinternal to the controller. The controller may also access data from,and store data in, memory that is not physically located within theelectronics module 120, such as on a server or a smartphone.

The sensor system 128 may include one or more sensors, including, forexample, one or more pressure sensors. The one or more pressure sensorsmay include a barometric pressure sensor (e.g., an atmospheric pressuresensor), a differential pressure sensor, an absolute pressure sensor,and/or the like. The sensors may employ microelectromechanical systems(MEMS) and/or nanoelectromechanical systems (NEMS) technology. Thesensor system 128 may be configured to provide an instantaneous pressurereading to the controller of the electronics module 120 and/oraggregated pressure readings over time. As illustrated in FIGS. 2 and 3,the sensor system 128 may reside within the inhalation device 100 butremain outside of the flow pathway 119. Accordingly, the sensor system128 may be configured to measure a plurality of atmospheric pressureswithin the inhalation device 100.

It will be appreciated that the atmospheric pressure within the device100 (e.g., within the top cap 102 or within the housing 104) may be thesame as or similar to the atmospheric pressure outside the device 100when the device 100 is not being used. However, when a user inhales fromthe mouthpiece 106, the user's inhalation may cause the atmosphericpressure within the device 100 to decrease. Conversely, an exhalationinto the mouthpiece 106 may cause the atmospheric pressure within thedevice 100 to increase. In both cases, the atmospheric pressure withinthe device 100 may differ from the atmospheric pressure outside of thedevice 100. Accordingly, certain parameters or metrics associated withthe inhalation or exhalation may be determined by comparing changes inatmospheric pressure resulting from the inhalation or exhalation.

The controller of the electronics module 120 may receive signalscorresponding to pressure measurements from the sensor system 128. Thecontroller may calculate or determine one or more airflow metrics (e.g.,a peak flow rate, a time to peak flow rate, an inhaled volume, aninhalation duration, etc.) using the signals received from the sensorsystem 128. The airflow metrics may be indicative of a profile ofairflow through the flow pathway 119 of the inhalation device 100. Forexample, if the sensor system 128 records a change in pressure of 0.3kilopascals (kPA), the electronics module 120 may determine that thechange corresponds to an airflow rate of approximately 45 liters perminute (Lpm) through the flow pathway 119. FIG. 7 shows an example ofairflow rates based on various pressure measurements. It will beappreciated that the airflow rates and profile shown in FIG. 7 aremerely examples and that determined rates may depend on the size, shape,and design of the inhalation device 100 and its internal components.

The airflow metrics may include one or more of an average flow of aninhalation/exhalation, a peak flow of an inhalation/exhalation (e.g., amaximum inhalation achieved), a volume of an inhalation/exhalation, atime to peak of an inhalation/exhalation, and/or the duration of aninhalation/exhalation. The airflow metrics may also be indicative of thedirection of flow through the flow pathway 119. That is, a negativechange in pressure may correspond to an inhalation from the mouthpiece106, while a positive change in pressure may correspond to an exhalationinto the mouthpiece 106. When calculating the airflow metrics, theelectronics module 120 may be configured to eliminate or minimize anydistortions caused by environmental conditions. For example, theelectronics module 120 may “zero out” to account for changes inatmospheric pressure before and/or after calculating the airflowmetrics. The one or more pressure measurements and/or airflow metricsmay be timestamped and stored in the memory of the electronics module120.

The controller of the electronics module 120 may compare signalsreceived from the sensor system 128 and/or the determined airflowmetrics to one or more thresholds or ranges, for example, as part of anassessment of how the inhalation device 100 is being used and/or whetherthe use is likely to result in the delivery of a full dose ofmedication. For example, where the determined airflow metric correspondsto an inhalation with an airflow rate below a particular threshold, theelectronics module 120 may determine that there has been no inhalationor an insufficient inhalation from the mouthpiece 106 of the inhalationdevice 100. If the determined airflow metric corresponds to aninhalation with an airflow rate above a particular threshold, theelectronics module 120 may determine that there has been an excessiveinhalation from the mouthpiece 106. If the determined airflow metriccorresponds to an inhalation with an airflow rate within a particularrange, the electronics module 120 may determine that the inhalation is“good”, or likely to result in a full dose of medication beingdelivered. As noted above, the electronics module 120 may includeindicators, such as an LED. The indicators may be configured to providefeedback to users regarding their use of the inhalation device 100.Thus, in one example, an LED may illuminate or change color if theairflow metrics correspond to a good inhalation or to no inhalation. Theairflow metrics may be computed and/or assessed via external devices aswell (e.g., partially or entirely).

More specifically, the wireless communication circuit 129 in theelectronics module 120 may include a transmitter and/or receiver (e.g.,a transceiver), as well as additional circuity. For example, thewireless communication circuit 129 may include a Bluetooth chip set(e.g., a Bluetooth Low Energy chip set), a ZigBee chipset, a Threadchipset, etc. As such, the electronics module 120 may wirelessly providedata such as pressure measurements, airflow metrics and/or otherconditions related to usage of the inhalation device 100, to an externaldevice, including a smartphone. The external device may include softwarefor processing the received information and for providing compliance andadherence feedback to users of the inhalation device 100 via a graphicaluser interface (GUI).

The battery 126 may provide power to the components of the PCB 122. Thebattery 126 may be any suitable source for powering the electronicsmodule 120, such as a coin cell battery, for example. The battery 126may be rechargeable or non-rechargeable. The battery 126 may be housedby the battery holder 124. The battery holder 124 may be secured to thePCB 122 such that the battery 126 maintains continuous contact with thePCB 122 and/or is in electrical connection with the components of thePCB 122. The battery 126 may have a particular battery capacity that mayaffect the life of the battery 126. As will be further discussed below,the distribution of power from the battery 126 to the one or morecomponents of the PCB 122 may be managed to ensure the battery 126 canpower the electronics module 120 over the useful life of the inhalationdevice 100 and/or the medication contained therein.

The electronics module 120 may have a plurality of power states, eachwith respective power consumption levels. For example, the electronicsmodule 120 may be configured to operate in a system off state, a sleepstate, and/or an active state. The system off state may be characterizedby very little or no power consumption, while the sleep state may becharacterized by greater power consumption than the off state, and theactive state may be characterized by greater power consumption than thesleep state. While the electronics module 120 is in the active state,the electronics module may operate in one or more modes, such as ameasurement mode, a data storage/data processing mode, an advertisingmode, and/or a connected mode. It should be appreciated that theelectronics module 120 may operate in multiple modes at one time (e.g.,the modes may overlap). For example, as described in more detail below,the electronics modules 120 may operate in the measurement mode and thedata storage/data processing mode at discrete times or simultaneously.That is, the electronics module 120 may be perform all of themeasurements prior to processing/storing the data, or the electronicsmodule 120 may perform data processing/storage while at the same timealso performing additional measurements (e.g., the electronics modules120 may switch between the measurement mode and the data storage/dataprocessing mode before either is complete).

In the system off state, the electronics module 120 may consume theleast amount of power as compared to the other power states (e.g., thesleep state and the active state). In particular, the electronics module120 may use a minimal amount of power to monitor a certain pin (or pins)on the controller but other components, such as the sensor system 128,the wireless communications circuit 129 (e.g., the Bluetooth radio) andmemory may be powered off. The pin on the controller may be inelectrical connection with the switch 130 such that actuation of theswitch 130 may result in a certain reference signal on the pin. Thereference signal may trigger the controller to transition from thesystem off state.

The system off state may be the initial state of the electronics module120 after the inhalation device 100 is assembled or manufactured. Thus,the electronics module 120 may be in a system off state prior to thedevice 100 being delivered to the user and/or prior to the mouthpiececover 108 being opened for a first time (e.g., before the first use ofthe inhalation device 100 by the user). In addition, once the mouthpiececover 108 has been opened for the first time, the electronics module 120may not return to the system off state thereafter. In some examples, thecontroller may start its internal clock (e.g., an internal counter) whenthe electronics module 120 first exits the off state, and any timestampdata generated by the electronics module 120 may be a relative timebased on internal clock of the controller. Accordingly, the internalclock may act as a counter that starts when the electronics module 120exits the off state. Alternatively or additionally, the controller mayinclude an internal system clock that knows the actual time (e.g., 4:05pm EST on Nov. 18, 2017) and the timestamp data may include the actualtime. In such examples, the controller may use power in the off state torun its real-time clock oscillator and to update its system clock.

As noted above, while the electronics module 120 is the active state,the electronics module 120 may operate in one or more modes, such as ameasurement mode, a data storage/data processing mode, an advertisingmode, and/or a connected mode. In the sleep state, the switch 130 andthe controller may continue to receive power from the battery 126, andthe controller may continue to run its oscillator and periodicallyupdate its system clock (e.g., continue to increment the internalcounter that was started when the electronics module 120 first exitedthe off state). In some examples, the controller may periodically updatethe system clock every 250 μs.

Further, while in the sleep state, the controller may receive power fromthe battery to control one or more additional components of theelectronics module 120. For example, during the advertising mode, thecontroller may periodically power on the communications circuit 129 towirelessly “advertise” to an external device that data is stored on theinhalation device 100 and is available for wireless download. Thecommunications circuit 129 may transmit advertising packets at anyinterval that is suitable for managing the power consumption of theelectronics module 120 when in the sleep state (e.g., as compared to theinterval at which packets may be sent during the active state). Forexample, advertising packets may be transmitted every 10 seconds whenthe electronics module 120 is operating in the sleep state. It will beappreciated that the electronics module 120 may spend more time in thesleep state than in any of the other power states. Thus, at a givenadvertising rate, the electronics module 120 may consume the most powerin the sleep state over the life of the inhalation device 100.

In the measurement mode, the controller of the electronics module 120may power on the sensor system 128. The controller may cause the sensorsystem 128 to take pressure measurement readings for a predeterminedtime period (e.g., up to 60 seconds) and/or until the mouthpiece cover108 is closed or no changes in pressure are detected. The controller mayturn off one or more components of the electronics module 120 while thesensor system 128 is capturing pressure measurement readings to furtherconserve power. The sensor system 128 may sample the pressure at anysuitable rate. For example, the sensor system 128 may have a sample rateof 100 Hz and thus a cycle time of 10 milliseconds. The sensor system128 may generate a measurement complete interrupt after the measurementcycle is complete. The interrupt may “wake” the controller or cause itto turn on one or more components of the electronics module 120. Forexample, after or while the sensor system 128 is sampling pressuremeasurements, the controller may process and/or store the pressuremeasurement data and, if measurements are complete, power off the sensorsystem 128.

In the data storage/data processing mode, the controller may power on atleast a portion of the memory within the electronics module 120. Thecontroller may process the readings from the sensor system 128 todetermine airflow metrics and store the airflow metrics in memory. Thecontroller may also compare the readings and/or the airflow metrics toone or more thresholds or ranges to assess how the inhalation device isbeing used (e.g., whether the pressure readings correspond to noinhalation, a “good” inhalation, to an exhalation, etc.). Depending onthe results of the comparison, the controller may drive the indicatorsto provide feedback to the user of the inhalation device 100. As notedabove, the electronics module 120 may operate in the measurement modeand the data storage/data processing mode simultaneously.

In the advertising mode, the controller may power on the communicationcircuit 129 (e.g., the Bluetooth radio) to advertise to an externaldevice that data is available from the inhalation device 100 and isready for wireless download. Advertising packets may be transmitted atany interval and for any duration that is suitable for managing thepower consumption of the electronics module 120 when in the advertisingmode. For example, the communications circuit 129 may transmitadvertising packets every 100 milliseconds (ms) for 3 minutes. Further,it should be appreciated that the advertising rate may vary based on theparticular conditions of the electronics module 120. For example, theadvertising rate may be “slow” (e.g., packets are transmitted every 10seconds) when the electronics module 120 is transitioning from the sleepstate and without the mouthpiece cover 108 moving to the open position,whereas the advertising rate may be “fast” (e.g., packets aretransmitted every 100 ms) after the measurements and dataprocessing/storage has occurred.

In the connected mode, the communication circuit and memory may bepowered on and the electronics module 120 may be “paired” with anexternal device, such as a smartphone. The controller may retrieve datafrom the memory and wirelessly transmit the data to the external device.The controller may retrieve and transmit all of the data currentlystored in the memory. The controller may also retrieve and transmit aportion of the data currently stored in the memory. For example, thecontroller may be able to determine which portions have already beentransmitted to the external device and then transmit the portion(s) thathave not been previously transmitted. Alternatively, the external devicemay request specific data from the controller, such as any data that hasbeen collected by the electronics module 120 after a particular time orafter the last transmission to the external device. The controller mayretrieve the specific data, if any, from the memory and transmit thespecific data to the external device.

The electronics module 120 may transition between power states oroperational modes based on certain conditions or events, such as theposition of the mouthpiece cover 108 and/or the elapse of predeterminedtime periods. For example, the mouthpiece cover 108 may be closed andthe electronics module 120 may be in a system off state or a sleepstate. As the mouthpiece cover 108 is moved from the closed position toan open position, the switch 130 may be actuated. The actuation of theswitch 130 may cause the electronics module 120 to transition from onestate (e.g., the system off state or sleep state) to another state(e.g., the active state). Further, as the actuation of the switch 130may cause the electronics module 120 to begin operating in one or moreoperational modes, such as the measurement mode and/or the datastorage/data processing mode. For example, FIG. 6A-B illustrate anexample flow diagram 200 that illustrates an example process fortransitioning between one or more power states and/or operational modesassociated with the inhalation device 100.

Further, it should be appreciated that the electronics module 120 may bein the system off state prior to the mouthpiece cover 108 being openedby a user for a first time (e.g., the initial opening of the mouthpiececover 108 by the user after removing the inhalation device 100 from itspackaging). Thereafter, if the mouthpiece cover 108 is returned to theclosed state, the electronics module 120 will be in the sleep state (asopposed to the off state). As the user continues to use the inhalationdevice 100, the electronics module 120 will switch between the sleepstate and the active state, based on, for example, one or more events(e.g., an opening/closing of the mouthpiece cover 108, the expiration ofa timeout period, the detection of pressure measurements that exceed athreshold (e.g., are indicative of user inhalation), advertising to anexternal device, etc.).

FIG. 5A-5D describe one example of the internal operation of aninhalation device 100. It should be appreciated that other examples ofthe inhalation device 100 may include a subset of the actions describedherein. Referring to FIG. 5A, the distal end 145 of the slider 140 maybe configured to abut the yoke 118 that resides within the main housing104. When the mouthpiece cover 108 is in the closed position, the arm142 of the slider 140 may not be in contact with the switch 130.Further, the slider spring 144 and the bellows spring 114 may be in acompressed state. As the user begins to open the mouthpiece cover 108 toexpose the mouthpiece 106, the yoke 118 may move upward in the mainhousing 104, for example, due to a mechanical connection between theyoke 118 and the mouthpiece cover 108. The upward movement of the yoke118 may cause the slider 140 to move upward within the top cap 102,further compressing the slider spring 144 and the bellows spring 114,for example, as shown in FIG. 5B.

As the mouthpiece cover 108 continues to move toward the fully openstate, for example as shown in FIG. 5C, the mouthpiece cover 108 maycause the yoke 118 to drop within the main housing 104 (e.g., due to thedownward force applied by the bellows spring 114). The movement of theyoke 118 may cause the slider 140 to drop (e.g., due to the downwardforce applied by the slider spring 144), which may cause the arm 142 ofthe slider 140 to engage the switch 130 and begin to actuate the switch130. The downward movement of the slider 140 may be limited by theposition of the yoke 118 as the distal end 145 of the slider 140 mayrest upon the top of the yoke 118.

As the mouthpiece cover 108 continues to open, as shown in FIG. 5D, thearm 142 of the slider 140 may actuate the switch 130, which may generatea signal causing the electronics module 120 to change states, such asfrom the off or sleep state to the active state. Thus, the controller ofthe electronics module 120 may wake and provide power to the sensorsystem 128 to enable the sensor system 128 to take pressure measurementreadings. Moreover, the movement of the yoke 118 caused by the openingof the mouthpiece cover 108 may also cause the yoke 118 to compress thebellows 112 to cause a bolus of medication to be delivered from themedication reservoir 110 to the dosing cup 116, resulting in themedication being made available to the flow channel 119. The medicationmay be delivered from the dosing cup 116 through the flow channel andout the mouthpiece 106 when a user inhales from the mouthpiece 106.

FIGS. 6A-B illustrate an example procedure 200 for transitioning betweenone or more power states and/or operational modes associated with theinhalation device 100. Although described with reference to theinhalation device 100, any inhalation device may perform the procedure200. The electronics module 120 of the inhalation device 100 may be inthe off state at 202, when the procedure 200 begins. The mouthpiececover 108 may be in the closed position and the user may not have openedthe mouthpiece cover 108 for the first time when the electronics module120 is in the off state at 202. As noted herein, the off state may becharacterized by little or no power consumption by the electronicsmodule 120. At 204, the electronics module 120 may determine whether themouthpiece cover 108 has been moved into the open position. If theelectronics module 102 determines that the mouthpiece cover 108 has notbeen moved into the open position, then the electronics module 120 mayreside in the off state at 202.

If the electronics module 120 determines that the mouthpiece cover 108has been moved into the open position at 204, then the electronicsmodule 120 may enter the system active state at 206. The active statemay be characterized by greater power consumption than the off state(e.g. and the sleep state). When in the active state, the electronicsmodule 120 may operate in one or more modes, such as a measurement mode,a data storage/data processing mode, an advertising mode, and/or aconnected mode. For example, the opening of the mouthpiece cover 108 maycause the switch 130 to be actuated. The actuation of the switch 130 maycause the electronics module 120 to transition from the off state to theactive state.

While in the active state, and after the mouthpiece cover 108 has beenopened, the electronics module 120 may enter a measurement mode at 208.During the measurement mode, the electronics module 120 may power on thesensor system 128 and may cause the sensor system 128 to take pressuremeasurement readings for a predetermined time period (e.g., up to 60seconds) and/or until the mouthpiece cover 108 is closed or no changesin pressure are detected.

In some examples, the electronics module 120 may remain in themeasurement mode until the pressure measurement cycle is complete. Thepressure measurement cycle may persist for a predetermined period oftime and/or until a particular event is detected. For example, thepressure measurement cycle may persist for up to 60 seconds, even if themouthpiece cover 108 has been closed and the slider 140 has disengagedfrom the switch 130. Alternatively, the pressure measurement cycle maypersist for up to 60 seconds or until the mouthpiece cover 108 has beenclosed or until no changes in pressure are detected for 10 seconds,whichever comes first. It will be appreciated that the foregoingconditions are merely examples and that any suitable criteria can beused.

At 212, the electronics module 120 may enter the data processing/datastorage mode. During the data processing/data storage mode, theelectronics module 120 may power on at least a portion of the memorywithin the electronics module 120. The electronics module 120 mayprocess the readings from the sensor system 128 to determine inhalationparameters/metrics and store the inhalation parameters/metrics inmemory. The electronics module 120 may also compare the readings and/orthe inhalation parameters/metrics to one or more thresholds or ranges toassess how the inhalation device is being used (e.g., whether thepressure readings correspond to no inhalation, a “good” inhalation, toan exhalation, etc.). Depending on the results of the comparison, theelectronics module 120 may drive the indicators to provide feedback tothe user of the inhalation device 100.

Although not illustrated by the procedure 200, the electronics module120 may operate in the measurement mode and the data storage/dataprocessing mode simultaneously. For example, the electronics module 120may switch (e.g., periodically switch) between the measurement mode andthe data processing/data storage mode. For example, after or while theelectronics module 120 is receiving pressure measurements, theelectronics module 120 may process and/or store the pressure measurementdata.

The electronics module 120 may remain in the data storage/dataprocessing mode for a predetermined period of time to process and storethe pressure measurement readings from the sensor system 128. Forexample, the electronics module 120 may remain in the data storage/dataprocessing mode for up to 60 ms. The electronics module 120 may, forexample, use up to 50 ms to process and compute airflow metrics from thepressure measurement readings and up to 10 ms to store the pressuremeasurements and/or airflow metrics in the memory. Alternatively, theelectronics module 120 may remain in the data storage/data processingmode for whatever duration it takes for the controller to process andstore the pressure measurement readings and/or air flow metrics.

The electronics module 120 may enter the advertising mode at 216. Forexample, the electronics module 120 may enter the advertising mode afterthe predetermined period of time for data processing and data storagehas elapsed, or after the controller has determined that such processingand storing are complete. During the advertising mode, the electronicsmodule 120 may power on the communication circuit 129 (e.g., theBluetooth radio) to advertise to an external device that data isavailable from the inhalation device 100 and is ready for wirelessdownload. Advertising packets may be transmitted at any interval and forany duration that is suitable for managing the power consumption of theelectronics module 120 when in the advertising mode. For example, thecommunications circuit 129 may transmit advertising packets every 100milliseconds (ms) for 3 minutes. Further, it should be appreciated thatthe advertising rate may vary based on the particular conditions of theelectronics module 120. For example, the advertising rate may be “slow”(e.g., packets are transmitted every 10 seconds) when the electronicsmodule 120 is transitioning from the sleep state and without themouthpiece cover 108 moving to the open position (e.g., whentransitioning from 230 to 216), whereas the advertising rate may be“fast” (e.g., packets are transmitted every 100 ms) after themeasurements and data processing/storage has occurred (e.g., whentransitioning from 212 to 216).

At 218, the electronics module 120 may determine if an external deviceis within range. If the external device does not come within aparticular range of the electronics module 120 during the advertisingmode, the electronics module 120 may determine whether an advertisingperiod (e.g., 3 minutes) has elapsed at 220. The advertising period maybe a period of time that the electronics module 120 continues toadvertise to an external device before changing power states. If theadvertising period has not elapsed, then the electronics module 120 maycontinue to advertise to the external device at 216. However, if theadvertising period has elapsed, then the electronics module 120 may moveto a sleep state at 222. The sleep state may be characterized by greaterpower consumption than the off state, but less power consumption thanthe on state.

The electronics module 120 may remain in the sleep state for apredetermined amount of time or until the electronics module determinesthat the mouthpiece cover 108 has been moved from the closed to the openposition. For example, the electronics module 120 may periodicallyswitch between the sleep state and the advertising mode (e.g., the slowadvertising mode) of the active state. For example, at 224, theelectronics module 120 may determine whether the mouthpiece cover 108has been moved from the closed to the open position. If the mouthpiececover 108 has been moved into the open position, then the electronicsmodule 120 may enter the active state at 206. For example, the openingof the mouthpiece cover 108 may cause the switch 130 to be actuated. Theactuation of the switch 130 may cause the electronics module 120 totransition from the sleep state to the active state.

If the electronics module 120 determines that the mouthpiece cover 108remains in the closed position, then the electronics module 120 maydetermine whether a sleep period (e.g., 10 seconds) has elapsed at 230.If the sleep period has not elapsed at 230, then the electronics module120 may stay in the sleep state and return to 222. However, if the sleepperiod has elapsed at 230, then the electronics module 120 may return tothe advertising mode of the active state at 216. When the electronicsmodule 120 transitions from 230 to 216, the electronics module 120 mayadvertises at a different, possibly slower rate as compared to when theelectronics module 120 transitions from 212 to 216 (e.g., such as onceevery 10 seconds as opposed to once every 100 ms). As such, theelectronics module 120 may use less battery power during suchadvertising modes. Further, the electronics module 120 may periodicallyswitch between the active state and the sleep state based on theadvertising period and the sleep period (e.g., and while the mouthpiececover 108 is in the closed position).

Returning to 218, if the external device (e.g., smartphone or tablet)comes within a particular range of the electronics module 120 during theadvertising mode, the electronics module 120 may “pair” with theexternal device and enter the connected mode at 226. In the connectedmode, the electronics module 120 may power on the communication circuitand memory. The electronics module 120 may retrieve data from the memoryand wirelessly transmit the data to the external device. At 228, theelectronics module 120 may determine whether the transmission iscomplete or the external device is out of communication range. If thetransmission is not complete and the external device is within thecommunication range, then the electronics module 120 will remain in theconnected mode. However, if the transmission is complete or if theexternal device is out of the communication range, then the electronicsmodule 120 will transition to the sleep state at 222.

During the connected mode, the electronics module 120 may retrieve andtransmit all of the data currently stored in the memory, or thecontroller may retrieve and transmit a portion of the data currentlystored in the memory. For example, the controller may be able todetermine which portions have already been transmitted to the externaldevice and then transmit the portion(s) that have not been previouslytransmitted (e.g., based on the internal counter). Alternatively oradditionally, the external device may request specific data from theelectronics module 120, such as any data that has been collected by theelectronics module 120 after a particular time or after the lasttransmission to the external device. The electronics module 120 mayretrieve the specific data, if any, from the memory and transmit thespecific data to the external device.

Further, when connected with the external device, the electronics module120 may be configured to transmit Bluetooth special interest group (SIG)characteristics for managing access to records stored in the module 120.The Bluetooth SIG characteristics may include one or more of amanufacturer name of the inhalation device 100, a serial number of theinhalation device 100, a hardware revision number of the inhalationdevice 100, and/or a software revision number of the inhalation device100. When connected with the external device, the electronics module 120may retrieve data from memory and transmit the data to the externaldevice.

The inhalation device 100 may transmit an inhalation event, aninhalation parameter, a pressure measurement, a mouthpiece cover 108event, an error event, an operating characteristic of the inhalationdevice (e.g., remaining battery life), and/or associated timestamps(e.g., based on the internal counter) to the external device when in theconnected mode. For example, the signals generated by the switch 130,the pressure measurement readings taken by the sensory system 128,and/or the airflow metrics computed by the controller of the electronicsmodules 120 may be timestamped and stored in memory. The foregoing datamay be indicative of various usage parameters associated with theinhalation device 100. For example, as movement of the slider 140 causesthe switch 130 to transition between “on” and “off”, the controller ofthe electronics module 120 may use the signals from the switch 130 torecord and timestamp each transition. Further, as the transition of theswitch 130 between “on” and “off” may correlate to the position of themouthpiece cover 108 (e.g., open or closed), the electronics module 120may be able to detect and track the position of the mouthpiece cover 108over time. It will be appreciated that the electronics module 120 may beable to sense and track the status of the mouthpiece cover 108 withoutinterfering with the delivery of medication through the flow pathway 119of the inhalation device 100.

The pressure measurement readings and/or the computed airflow metricsmay be indicative of the quality or strength of inhalation from theinhalation device 100. For example, when compared to a particularthreshold or range of values, the readings and/or metrics may be used tocategorize the inhalation as a certain type of event, such as a goodinhalation event, a low inhalation event, a no inhalation event, or anexcessive inhalation event.

The no inhalation event may be associated with pressure measurementreadings and/or airflow metrics below a particular threshold, such as anairflow rate less than 30 Lpm. The no inhalation event may occur when auser does not inhale from the mouthpiece 106 after opening themouthpiece cover 108 and during the measurement cycle. The no inhalationevent may also occur when the user's inspiratory effort is insufficientto ensure proper delivery of the medication via the flow pathway 119,such as when the inspiratory effort generates insufficient airflow toactivate the deagglomerator 121 and, thus, aerosolize the medication inthe dosing cup 116.

The low inhalation event may be associated with pressure measurementreadings and/or airflow metrics within a particular range, such as anairflow rate between 30 Lpm and 45 Lpm. The low inhalation event mayoccur when the user inhales from the mouthpiece 106 after opening themouthpiece cover 108 and the user's inspiratory effort causes at least apartial dose of the medication to be delivered via the flow pathway 119.That is, the inhalation may be sufficient to activate the deagglomerator121 such that at least a portion of the medication is aerosolized fromthe dosing cup 116.

The good inhalation event may be associated with pressure measurementreadings and/or airflow metrics above the low inhalation event, such asan airflow rate between 45 Lpm and 200 Lpm. The good inhalation eventmay occur when the user inhales from the mouthpiece 106 after openingthe mouthpiece cover 108 and the user's inspiratory effort is sufficientto ensure proper delivery of the medication via the flow pathway 119,such as when the inspiratory effort generates sufficient airflow toactivate the deagglomerator 121 and aerosolize a full dose of medicationin the dosing cup 116.

The excessive inhalation event may be associated with pressuremeasurement readings and/or airflow metrics above the good inhalationevent, such as an airflow rate above 200 Lpm. The excessive inhalationevent may occur when the user's inspiratory effort exceeds the normaloperational parameters of the inhalation device 100. The excessiveinhalation event may also occur if the device 100 is not properlypositioned or held during use, even if the user's inspiratory effort iswithin a normal range. For example, the computed airflow rate may exceed200 Lpm if the air vent 126 is blocked or obstructed (e.g., by a fingeror thumb) while the user is inhaling from the mouthpiece 106.

It will be appreciated that any suitable thresholds or ranges may beused to categorize a particular event. It will further be appreciatedthat some or all of the events may be used. For example, the noinhalation event may be associated with an airflow rate below 45 Lpm andthe good inhalation event may be associated with an airflow rate between45 Lpm and 200 Lpm. As such, the low inhalation event may not be used atall in some cases.

The pressure measurement readings and/or the computed airflow metricsmay also be indicative of the direction of flow through the flow pathway119 of the inhalation device 100. For example, if the pressuremeasurement readings reflect a negative change in pressure, the readingsmay be indicative of air flowing out of the mouthpiece 106 via the flowpathway 119. If the pressure measurement readings reflect a positivechange in pressure, the readings may be indicative of air flowing intothe mouthpiece 106 via the flow pathway 119. Accordingly, the pressuremeasurement readings and/or airflow metrics may be used to determinewhether a user is exhaling into the mouthpiece 106, which may signalthat the user is not using the device 100 properly.

By timestamping and storing the signals generated by the switch 130, thepressure measurement readings taken by the sensory system 128, and/orthe airflow metrics computed by the controller of the electronics module120, the data collected and stored by the electronics module 120 may beused to determine whether the usage parameters are suitable orappropriate over a given period of time. As such, the data may beindicative of other events, such as an overuse event, an underuse event,or an optimal use event.

For example, the user of the inhalation device 100 may be prescribed byhis or her doctor to take two doses of medication via the inhalationdevice 100 each day. In addition, the medication contained in theinhalation device 100 may also be approved (for safety and regulatorypurposes) to be taken no more eight times each day. The overuse eventmay occur if the electronics module 120 records more than two goodinhalations in a twenty-four hour period (i.e., the actual dosing isexceeding the prescribed number of doses) and/or if the electronicsmodule 120 records more than eight good inhalations in a twenty-fourhour period (i.e., the actual dosing is exceeding the regulatoryapproved number of doses). The underuse event may occur if theelectronics module 120 records less than two good inhalations in atwenty-four hour period (i.e., the actual dosing is below the prescribednumber of doses). The optimal use event may occur if the electronicsmodule 120 records two good inhalations in a twenty-four hour period(i.e., the actual dosing is below the prescribed number of doses). Itwill be appreciated that optimal use events may be indicative of a userwho is adherent. It will further be appreciated that the prescribeddosing schedule and/or the maximum approved dosing schedule may dependon the type of medication contained in the inhalation device 100. Inaddition, the events may be defined using any suitable number of dosesover any suitable period of time, such as two doses per day, fourteendoses per week, 60 doses per month, etc.

The data collected and stored by the electronics module 120 may also beused to estimate the number doses that have been delivered from theinhalation device 100 and/or estimate the number of doses that remain inthe medication reservoir 110. For example, each time the switch 130 isactivated via the opening of the mouthpiece cover 108, the signalgenerated by the switch 130 may be counted as a dose delivery event.Thus, the inhalation device 100 may be deemed to have delivered 60 doseswhen the mouthpiece cover 108 is opened 60 times. The inhalation device100 may be configured to store enough medication in the medicationreservoir 110 to deliver a predefined total number of doses, such as atotal of 200 doses. As such, the inhalation device 100 may also bedeemed to have 140 doses remaining after the mouthpiece cover 108 isopened 60 times.

As noted above, medication will not be delivered from the medicationreservoir 110 upon the user opening the mouthpiece cover 108 if aprevious dose of medication was not properly aerosolized by thedeagglomerator 121 and/or transferred from the dosing cup 116. Thus, itwill be appreciated that counting the number of doses based on theopening of the mouthpiece cover 108 may not accurately reflect theactual number of doses delivered by the device 100 if, for example, auser opens and closes the mouthpiece cover 108 without inhaling from themouthpiece 106. Accordingly, other data in the electronics module 120may be used and/or combined with the signals from the switch 130 todetermine the number of doses delivered and/or remaining in the deice100. For example, a dose may be counted as delivered each time acomputed airflow metric is above a threshold or within a particularrange, such as when a good inhalation event has been recorded. Bycalculating and tracking the number of doses delivered and/or remaining,the electronics module 120 may be configured to identify a refill event,which may be indicative of a time when a user should consider obtaininga new inhalation device 100.

The data collected and stored by the electronics module 120 may also beused to determine various error conditions associated with the operationof the module 120. For example, when processing the data the electronicsmodule 120 may generate a bad data flag, a data corrupt flag, atimestamp error flag, and/or the like. The electronics module 120 maygenerate the bad data flag when the controller of the electronics module120 determines that one or more signals received from the sensor system128 are outside a predetermined range, which may indicate a malfunctionin the sensor system 128. The electronics module 120 may generate thedata corrupt flag when the controller's cyclic redundancy check (CRC) ofdata does not match what is stored in memory, which may indicate amalfunction of the memory and/or that the data in the memory has beencorrupted. The electronics module 120 may generate a timestamp errorflag when the controller loses its electrical connection with thebattery 126, causing the controller's system clock to reset. If thecontroller's system clock is reset, the controller may restart its clockfrom the last stored counter value.

The electronics module 120 (e.g., and/or a mobile application residingon an external device) may also analyze the recorded events over aperiod of time to identity multiple error events, which may include apattern of use indicative of a user who is not familiar with the properoperation of the inhalation device 100 and thus a user who may requirefurther training. For example, the electronics module 120 may look atthe number of good inhalation events over a predetermined period of timeand/or over a predetermined number of openings of the mouthpiece cover108. A multiple error event may occur when a user has had only two goodinhalation events over the past week, or has had six or less goodinhalations over the last twelve openings of the mouthpiece cover 108.It will be appreciated that the foregoing conditions are merelyexemplary and that any suitable pattern of use may be used to define amultiple error event.

The data collected and stored by the electronics module 120 may also beused to assess the amount of power remaining in the battery 126. Forexample, the controller may determine whether there is a low batteryevent or condition, such as whether the battery has less than apredetermined amount of charge remaining (e.g., below 10%).

It will be appreciated that electronics module 120 may process andanalyze the data stored in memory (e.g., the signals generated by theswitch 130, the pressure measurement readings taken by the sensorysystem 128 and/or the airflow metrics computed by the controller of thePCB 122) to determine the usage parameters associated with theinhalation device 100. For example, the electronics module 120 mayprocess the data to identify no inhalation events, low inhalationsevents, good inhalation events, excessive inhalation events and/orexhalation events. The electronics module 120 may also process the datato identify underuse events, overuse events and optimal use events. Theelectronics module 120 may further process the data to estimate thenumber of doses delivered and/or remaining and to identify errorconditions, such as those associated with a timestamp error flag. Theelectronics module 120 may inform the user of some or all of theforegoing usage parameters of the inhalation devoice 100 using theindicators, such as one or more LEDs. As an example, the electronicsmodule 120 may illuminate an LED to indicate a good inhalation event orchange the color of an LED to indicate a low inhalation event or a noinhalation event. The usage parameters may be indicated to the user viaany combination of light sequences and/or light color schemes.

It will further be appreciated that the data stored in the memory of theelectronics module 120 (e.g., the signals generated by the switch 130,the pressure measurement readings taken by the sensory system 128 and/orthe airflow metrics computed by the controller of the electronics module120) may also be transmitted to an external device, which may processand analyze the data to determine the usage parameters associated withthe inhalation device 100. Further, a mobile application residing on themobile device may generate feedback for the user based on data receivedfrom the electronics module 120. For example, the mobile application maygenerate daily, weekly, or monthly report, provide confirmation of errorevents or notifications, provide instructive feedback to the user,and/or the like.

FIG. 8 is a diagram of an example system 300 including an inhalationdevice 302, an external device (e.g., a mobile device 304), a publicand/or private network 306 (e.g., the Internet, a cloud network), ahealth care provider 308, and a third party 310 (e.g., friends, family,pharmaceutical manufacturer, etc.). The mobile device 304 may include asmart phone (e.g., an iPhone® smart phone, an Android® smart phone, or aBlackberry® smart phone), a personal computer, a laptop, awireless-capable media device (e.g., MP3 player, gaming device,television, a media streaming devices (e.g., the Amazon Fire TV, NexusPlayer, etc.), etc.), a tablet device (e.g., an iPad® hand-heldcomputing device), a Wi-Fi or wireless-communication-capable television,or any other suitable Internet-Protocol-enabled device. For example, themobile device 304 may be configured to transmit and/or receive RFsignals via a Wi-Fi communication link, a Wi-MAX communications link, aBluetooth® or Bluetooth Smart communications link, a near fieldcommunication (NFC) link, a cellular communications link, a televisionwhite space (TVWS) communication link, or any combination thereof. Themobile device 304 may transfer data through the public and/or privatenetwork 306 to the health care provider 308 and/or one or more thirdparties 310 (e.g., friends, family, pharmaceutical company, etc.).

The inhalation device 302 may be an example of the inhalation device100. The inhalation device 302 may include a communication circuit, suchas a Bluetooth radio, for transferring data to the mobile device 304.The data may include the signals generated by the switch 130, thepressure measurement readings taken by the sensory system and/or theairflow metrics computed by the controller of the electronics module.The inhalation device 302 may receive data from the mobile device 304,such as, for example, program instructions, operating system changes,dosage information, alerts or notifications, acknowledgments, etc.

The mobile device 304 may process and analyze the data to determine theusage parameters associated with the inhalation device 302. For example,the mobile device 304 may process the data to identify no inhalationevents, low inhalations events, good inhalation events, excessiveinhalation events and/or exhalation events. The mobile device 304 mayalso process the data to identify underuse events, overuse events andoptimal use events. The mobile device 304 may further process the datato estimate the number of doses delivered and/or remaining and toidentify error conditions, such as those associated with a timestamperror flag. The mobile device 304 may include a display and software forvisually presenting the usage parameters through a GUI on the display.

Further, in some examples, the inhalation device 300 may include anactuator to initiate a pairing process with the mobile device 304.However, the inhalation device 300 may include other means forfacilitating the pairing process. For example, the top cap of theinhalation device 300 may include a Quick Response (QR) code. The mobiledevice 304 may include a camera and software application for accessingthe camera and reading the QR code. The QR code may include a BLEpasskey that is unique to the inhalation device 300. Upon reading orscanning the QR code using the camera, the software application mayreceive the BLE passkey associated with the device 300 and complete anauthentication process, thereby enabling it to communicate with theelectronics module using the BLE passkey. If the communications sessionis subsequently lost because, for example, the inhalation device 300moves out of range, the mobile device 304 may be configured to use theBLE passkey to automatically pair with the electronics module withoutusing the QR code when the inhalation device 300 is back within range.

What is claimed is:
 1. An inhaler for delivering medication to a user,the inhaler comprising: a main body having a mouthpiece and a mouthpiececover; a slider at least partially disposed within the main body; and anelectronics module having a switch; wherein the electronics module isconfigured to be in an off state prior to a user moving the mouthpiececover to expose the mouthpiece for the first time; wherein, when themouthpiece cover is moved to expose the mouthpiece, the slider isconfigured to engage the switch, causing the electronics module totransition from the off state to an active state and to sense aninhalation by the user from the mouthpiece, and wherein the electronicsmodule is configured to not return to the off state after the mouthpiececover is moved to expose the mouthpiece for the first time by the user.2. The inhaler of claim 1, wherein the electronics module is configuredto start an internal counter when transitioning from the off state. 3.The inhaler of claim 2, wherein the electronics module is configured totimestamp a sensed inhalation or an opening of the mouthpiece coverbased on the internal counter.
 4. The inhaler of claim 1, wherein theelectronics module further comprises a pressure sensor configured tomeasure at least one atmospheric pressure within the inhaler after themouthpiece cover is moved from the closed position to the open position.5. The inhaler of claim 4, wherein the pressure sensor is configured totake measurements for a predetermined period of time or until apredetermined event is detected.
 6. The inhaler of claim 4, wherein theelectronics module further includes a processor configured to determineone or more inhalation parameters based on the at least one measuredatmospheric pressures.
 7. The inhaler of claim 6, wherein the inhalationparameters comprise: a peak flow rate; a time to peak flow rate; aninhaled volume; and an inhalation duration.
 8. The inhaler of claim 6,wherein the electronics module further includes a communications circuitconfigured to wirelessly transmit the inhalation parameters to anexternal device.
 9. The inhaler of claim 1, wherein, when in the activestate, the electronics module is configured to perform at least one ofthe following: measure one or more atmospheric pressures within theinhaler after the mouthpiece cover is moved to expose the mouthpiece;determine inhalation parameters based on the at least one measuredatmospheric pressures; store the inhalation parameters in a localmemory; advertise to an external device; and transmit the inhalationparameters to the external device.
 10. The inhaler of claim 2, whereinthe electronics module is configured to be in a sleep state when not inthe off state or the active state.
 11. The inhaler of claim 10, whereinthe electronics module is configured to change from the active state tothe sleep state upon the electronics module determining that one or moreatmospheric pressure measurements received from a pressure sensor do notfall within the predetermined range for a predetermined amount of time,the predetermined amount of time based on the internal counter.
 12. Theinhaler of claim 11, wherein the electronics module is configured tostore a timeout event and associated timestamp when the mouthpiece coveris moved to expose the mouthpiece and the one or more atmosphericpressure measurements are not within the predetermined range within thepredetermined amount of time.
 13. The inhaler of claim 1, wherein theelectronics module is configured to change from the active state to asleep state upon the mouthpiece cover being moved to cover themouthpiece.
 14. A method for delivering medication via an inhaler withan electronics module, the method comprising: maintaining theelectronics module in an off state prior to a user moving a mouthpiececover to expose a mouthpiece for the first time; actuating a switch whenthe mouthpiece cover is moved to expose the mouthpiece; transitioningthe electronics module from the off state to an active state when theswitch is actuated; sensing an inhalation of a user from the mouthpiece;and delivering a dose of medication; wherein the electronics module isconfigured to not return to the off state after the mouthpiece cover ismoved to expose the mouthpiece for the first time by the user.
 15. Themethod of claim 14, further comprising making the dose of medicationavailable to a flow channel of the mouthpiece when the mouthpiece coveris moved to expose the mouthpiece.
 16. The method of claim 14, furthercomprising starting an internal counter via a processor within theelectronics module when transitioning from the off state.
 17. The methodof claim 16, further comprising timestamping the sensed inhalation orthe movement of the mouthpiece cover based on the internal counter. 18.The method of claim 14, further comprising transitioning the electronicsmodule to a sleep state when not in the off state or the active state.19. The method of claim 14, wherein the switch is engaged by a sliderthat is at least partially disposed within a housing of the inhaler. 20.The method of claim 14, further comprising measuring, via a sensor ofthe electronics module, a plurality of atmospheric pressures within theinhaler.
 21. The method of claim 20, further comprising measuring theplurality of atmospheric pressures until a predetermined event isdetected or for a predetermined period of time after the mouthpiececover is moved to expose the mouthpiece.
 22. The method of claim 20,further comprising determining, via the electronics module, one or moreinhalation parameters based on the plurality of measured atmosphericpressures.
 23. The method of claim 22, wherein the inhalation parameterscomprise: a peak flow rate; a time to peak flow rate; an inhaled volume;and an inhalation duration.
 24. The method of claim 22, furthercomprising wirelessly transmitting the inhalation parameters to anexternal device.
 25. The method of claim 14, further comprising theelectronics module performing at least one of the following when in theactive state: measuring one or more atmospheric pressures within theinhaler; determining inhalation parameters based on the one moremeasured atmospheric pressures; storing the inhalation parameters in alocal memory; advertising to an external device; and transmitting theinhalation parameters to the external device.